South Africa medical device regulatory resources

SAHPRA communication MD019 §3: establishment licence applications are processed within 6-8 weeks, and the same figure is repeated in the licensing FAQ

An expedited pathway aiming to conclude within 10-15 working days exists but is scoped to devices and IVDs required during the COVID-19 pandemic under MD005, so it is not generally available

The clock is conditional on the applicant: a deficiency observation letter must be answered within 10 working days on the standard route or 2 working days on the expedited one, only two response cycles are permitted, and a third round or a missed deadline ends the licensing process with no recommendation

One clock covers the whole route and it does not vary by device class

SAHPRA licence-renewal Q&A §3.5: processing "may be for a period of at least 4 to 8 weeks", so the lower bound is a floor rather than a promise

The renewal application must be filed at least 90 days before the licence expiry date, and licensees whose licence had already lapsed at publication were given a grace period of up to 90 days

Product-list changes can ride along with the renewal without a separate amendment as long as the licensed device class does not change; address, company-name, activity, Class D additions and responsible-person changes are amendments that carry an extra fee and can only be filed after the renewed licence has been issued